SFU · Glucose Range Monitoring System

Clinical Chemistry · 21 CFR 862.1359 · Class 2

Overview

Identification

The Biolinq Shine Autonomous Time-in-Range Microsensor consists of a continuous intradermal glucose sensor with a color-changing indicator light. It is intended to measure, record, and analyze physiologic data using an array of microsensors combined with an accelerometer and ambient light sensor. The qualitative display communicates real-time changes in glucose levels to aid in the management of a disease or condition related to glycemic control in persons 22 years or older not on insulin. An app provides more granular glucose information, analyzing and correlating glucose information with meals, rest, and activity levels to facilitate acute behavior and lifestyle modifications.

Classification Rationale

FDA concludes that this device should be classified into Class II. This order classifies the Biolinq Shine Autonomous Time-in-Range Microsensor, and substantially equivalent devices of this generic type, into Class II under the generic name glucose range monitoring system, with the establishment of special controls for class II to provide reasonable assurance of the safety and effectiveness of the device type.

Special Controls

In combination with the general controls of the FD&C Act, the glucose range monitoring system is subject to the following special controls: (1) Design verification and validation must include the following: (i) Robust clinical data must demonstrate the accuracy of the device for its intended use. (ii) The clinical data must include a comparison between GRM outputs and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order (e.g., an internationally recognized reference material and/or method). Performance must be assessed using appropriate statistical methods for the type of output. (iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device. (iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period. (v) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent the GRM from achieving its intended use. (2) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section. (3) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications. (4) The device must include appropriate measures to ensure that a disposable sensor cannot be used beyond its claimed sensor wear period. (5) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and correctly interpret device outputs, contraindications, warnings, precautions, and limitations, as applicable. (6) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different GRM insertion or use sites (e.g., abdomen, arm, buttock): (i) A description of all device outputs, including glucose data as well as information generated by the device based on the glucose data, their intended purposes, and limitations. (ii) A description of the accuracy of the glucose data. (iii) A description of the frequency and duration of gaps in sensor data. (iv) A description of the observed duration of GRM life for the device. (v) A statement that the device is not intended for insulin dosing, medication adjustment, or other acute medical decision making.

Recent Cleared Devices (1 of 1)

Top Applicants

• Biolinq Incorporated — 1 clearance